Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ECOG-E2Z02 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Questionnaires that assess symptoms caused by cancer and cancer therapy may help improve the ability to plan treatment for patients with invasive cancer to help them live longer and more comfortably.
PURPOSE: This clinical trial is studying symptoms caused by cancer and cancer therapy in patients with invasive breast, lung, prostate, or colorectal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease type, prevalence according to gender, race/ethnicity, age, and type of treatment.
Patients complete the M.D. Anderson Symptom Assessment Inventory and other questionnaires, rating the symptoms most frequently found in this patient group and how much these symptoms interfere with mood and activity-related domains, on day 1 and again between days 28-35.
At the same time points, a healthcare provider (treating physician, nurse, or physician assistant) completes the Revised Edmonton Staging System for Cancer Pain questionnaire, assessing the patient's cancer pain on the basis of mechanism of pain, incidental pain, psychological distress and addictive behavior, and cognitive function, for clinical prognosis on pain control.
PROJECTED ACCRUAL: A total of 2,310 patients and their physicians will be accrued for this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| assessment of therapy complications | Procedure | |||
| cognitive assessment | Procedure | |||
| psychosocial assessment and care | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence, severity, and interference due to physical and psychological symptoms experienced by cancer patients as assessed by MD Anderson Symptom Inventory at baseline and days 28-35 following initial assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of symptom-related interventions related to the providers perception of symptom severity as assessed by The Revised Edmonton Staging System for cancer pain (rESS) at baseline and days 28-35 following initial assessment | ||
| Compare treatment priority based on physical or psychological symptoms |
Not provided
DISEASE CHARACTERISTICS:
Being seen in an outpatient setting at an ECOG-affiliated academic institution, a CGOP site, or a CCOP site
Clinically diagnosed invasive cancer involving at least 1 of the following primary sites:
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael J. Fisch, MD, MPH, FACP | M.D. Anderson Cancer Center | Study Chair |
| Charles Cleeland, PhD | M.D. Anderson Cancer Center |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Manola J, Zhao F, Miller AH, et al.: Patterns of antidepressant use in cancer patients (pts): An analysis from SOAPP (ECOG E2Z02: Symptom Outcomes and Practice Patterns). [Abstract] J Clin Oncol 30 (Suppl 15): A-9016, 2012. | ||
| Result | Zhao F, Wagner LI, Pirl WF, et al.: Racial disparities in depressive symptom prevalence and selective serotonin reuptake inhibitor (SSRI) utilization in cancer patients: An analysis from ECOG E2Z02: Symptom Outcomes and Practice Patterns (SOAPP). [Abstract] J Clin Oncol 30 (Suppl 15): A-6076, 2012. | ||
| Result | Wagner LI, Zickl L, Smith ML, et al.: Prospective assessment of symptom burden among cancer survivors with common solid tumors: results from ECOG trial E2Z02. [Abstract] J Clin Oncol 29 (Suppl 15): A-9137, 2011. | ||
| Result | Hamann HA, Lee J, Schiller JH, et al.: Clinician perceptions of care difficulty and quality of life for lung cancer patients: results from the ECOG SOAPP study (E2Z02). [Abstract] J Clin Oncol 28 (Suppl 15): A-9102, 2010. | ||
| Result | Tevaarwerk A, Lee J, Sesto MC, et al.: Predictors of employment (empl) outcomes in outpatients (pts) with common solid tumors: A secondary analysis from E2Z02 (ECOG's SOAPP study). [Abstract] J Clin Oncol 28 (Suppl 15): A-9118, 2010. | ||
| 24366929 |
Not provided
Not provided
| Percentage of patients who experience a significant reduction in moderate-to-severe symptoms and characterize the determinants of symptom relief |
| Focus and scope of interventions chosen to improve symptom control |
| John H. Stroger, Jr. Hospital of Cook County |
| Chicago |
| Illinois |
| 60612-3785 |
| United States |
| Evanston Hospital | Evanston | Illinois | 60201-1781 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States |
| Howard Community Hospital | Kokomo | Indiana | 46904 | United States |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Saint Joseph Regional Medical Center | South Bend | Indiana | 46617 | United States |
| South Bend Clinic | South Bend | Indiana | 46617 | United States |
| McFarland Clinic, PC | Ames | Iowa | 50010 | United States |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City | Iowa | 50401 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51104 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123-2500 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Foote Memorial Hospital | Jackson | Michigan | 49201 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48912-1811 | United States |
| St. Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341-2985 | United States |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | 48060 | United States |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | 48601 | United States |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| Derived |
| Zhao F, Chang VT, Cleeland C, Cleary JF, Mitchell EP, Wagner LI, Fisch MJ. Determinants of pain severity changes in ambulatory patients with cancer: an analysis from Eastern Cooperative Oncology Group trial E2Z02. J Clin Oncol. 2014 Feb 1;32(4):312-9. doi: 10.1200/JCO.2013.50.6071. Epub 2013 Dec 23. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| D010146 | Pain |
| D011471 | Prostatic Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D018567 | Breast Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided